WINSTON-SALEM, N.C., Nov. 21, 2011- Interventional cardiologists have waited 30 years for a successful way to clear atherosclerotic plaque from a particularly complicated type of heart vessel. Now clinical researchers at Wake Forest Baptist Medical Center are testing a new investigational device to determine if it will work.
It’s called the Tryton Side Branch Stent System™. This is a bifurcation stent, named after a complex coronary artery with two large branches that are shaped like a V. Michael A. Kutcher, M.D., Professor of Internal Medicine-Cardiology at Wake Forest Baptist, is the primary investigator of this Phase 2 trial designed to study whether the bifurcated stent will prove more safe and effective than conventional stenting techniques. “It is one of the last big innovations in cardiac stenting,” said Kutcher. “We are honored to contribute to this national and international study of an innovative stent design for a complex coronary artery problem.”
Literally millions of Americans are treated for heart attack each year. Most often they undergo percutaneous coronary intervention (PCI) procedures in a cardiac catheterization lab to clear their clogged heart vessels with a stent, delivered via catheter and without open heart surgery. At Wake Forest Baptist alone, an estimated 30,000 patients have undergone PCI procedures since the early 1980s.
While bifurcation blockages account for only 10 percent of all PCIs, conventional stenting of these branch vessels is complex and can accidently block of one of the branches, resulting in a heart attack. Even if successful, bifurcation stent procedures tend to have a higher rate of recurrence, resulting in the need for repeat procedures or even open heart surgery. Kutcher notes that this trial continues the focus that he and his interventional cardiology colleagues have to improve patient therapy options in the most complicated cases of heart disease.
This stent has not been approved for commercial use in the United States by the Food and Drug Administration, but has been tested and approved for use in Europe for the past year. Initial results published in national and international peer-reviewed medical journals have found that the bifurcation device is safe and effective but needs to be evaluated further in a larger patient population of a multi-center randomized clinical trial.
For Kutcher, this trial also takes on a more personal note. The Tryton Side Branch Stent System™ was developed by one of his former medical students, Aaron Kaplan, M.D., now at Dartmouth Medical Center. “As a medical student at Wake Forest, Aaron observed some of our first PCI procedures. He later told me that it inspired him to use his undergraduate background in engineering.”
Kaplan has gone on to an impressive career in interventional cardiology device development, first at Stanford, and now at Dartmouth. “His success is a great compliment to the educational mission of Wake Forest Baptist,” said Kutcher, “so, it has now come full circle.”